ANDA

CHARAK COLLEGE OF PHARMACY AND
RESEARCH WAGHOLI,PUNE
ABBREVIATED NEW DRUG APPLICATION (ANDA)
GUIDED BY : DR.A.V BHALERAO MAM

PRESENTED BY : SHUBHAM S SULE HOD OF PHARMACEUTICS
M-PHARM 1ST YEAR (PQA) CHARAK COLLEGE OF PHARMACY PUNE
ROLL NO : 515
Content
 Abbreviated New Drug Application

 Basic Generic Drug Requirements
 Goal of ANDA
 (ANDA)Review process
 What Is Bioavilability And Bioequivalence?
 FILING OF ANDA
 What is Bioequivalence?
 Module
 Filing Of Anda Contents
 Patent Certification condition for ANDA
 Paragraph IV certification
 Patent Challenge Successful – Award of 180-Day Exclusivity Period
 180-Day Generic Drug Exclusivity under the Hatch-Waxman Amendments to
the Federal Food, Drug, and Cosmetic Act
 Orphan Drug Exclusivity (ODE)
 The Hatch-Waxman Amendments
 Conclusion
 References
Abbreviated New Drug Application (ANDA)
 An Abbreviated New Drug Application is an application for a U.S. generic drug

approval for an existing licensed medication ( innovator drug ) or approved drug.
 The ANDA is submitted to FDA’s Center, for Drug Evaluation and Research, Office of
Generic Drugs (OGD), which provides for the review and ultimate approval of a
generic drug product.
 Once approved an applicant may manufacture & market the generic drug product
 Generic drug applications are termed “abbreviated” because they are generally not
required to include preclinical (animal) & clinical (human) data to establish safety &
effectiveness.
 All approved products, both innovator & generic, are listed in FDA’s orange book with
Therapeutic Equivalence Evaluations.
Basic Generic Drug Requirements are
 Same active ingredient(s)

 Same route of administration
 Same dosage form
 Same strength
 Same conditions of use
Goal of ANDA
 To reduce the price of the drug.
 To reduce the time development.
 Increase the bioavailability of the drug in comparison to references list drug.

Abbreviated New Drug Application
(ANDA)Review process
What Is Bioavilability And Bioequivalence ?
Bioavailability :
 It is defined as the rate and extent to which active ingredients is absorbed from a drug
product and becomes available at the site of action.
Bioequivalence :
 The absence of a significant difference in the rate and extent to which the active
ingredients becomes available at the site of action when administered at the same mole
dose under similar conditions.
What is Bioequivalence ?
A generic drug is considered to be bioequivalent to the brand name drug if:
 The rate and extent of absorption do not show a significant difference from
listed drug, or
 The extent of absorption does not show a significant difference and any
difference in rate is intentional or not medically significant
Module 1- Administrative Information and Prescribing Information
 This module contain document specific to each region. The content and format of this
module can be specified by relevant regulatory authorities.
Module 2- Common Technical Document Summaries
 It should begin with general introduction to pharmaceuticals including its
pharmacological class, mode of action and proposed clinical use.
Module 3- Quality
 Information on quality as mentioned in ICH guideline M4Q
Module 4- Non clinical study report
 Not required in ANDA filing
Module 5- Clinical study report
 The human study report and related information in order described in ICH guideline M4E
Filing Of
ANDA
OGD - OFFICE OF GENERIC DRUG
CDER - CENTER FOR DRUG

EVALUATION AND RESEARCH
Applicant
An applicant means any person (usually a pharmaceutical firm) who submits an
abbreviated new drug application, or an amendment or supplement to them, to obtain FDA
approval to market a generic drug product.
Acceptable & Complete ?

An application must contain sufficient information to allow a review to be
conducted in an efficient & timely manner.
Upon receipt of the application a pre-filling assessment of its completeness &
acceptability is performed by a project manager within the regulatory support
branch, Office of Generic Drugs.
If this initial review documents that the applicant contains all the necessary
components, an “acknowledgment letter” is sent to the applicant.
Refuse to file letter issued
 If the application is missing one or more essential components, a “Refuse to

File” letter is sent to the applicant.
 No further review of the application occurs until the applicant provides the
requested data & the application is found acceptable & complete.
Bioequivalence Review
 The Bioequivalence Review process established that the proposed generic drug is
bioequivalent to the reference listed drug, based upon a demonstration that
both the rate & extent of absorption of the active ingredient of the generic drug
fall within established parameters when compared to that of the reference
listed drug.
 Alternatively, in vivo bioequivalence testing comparing the rate & extent of
absorption of the generic vs. the reference product is required for most tablet &
capsule dosage forms. For certain products, a head to head evaluation of
comparative efficacy based upon clinical endpoints may be required.
Chemistry/Microbiology Review
 The Chemistry/Microbiology review process provides assurance that the

generic drug will be manufactured in a reproducible manner under controlled
conditions.
 Areas such as the applicant’s manufacturing procedures, raw material
specifications & controls, sterilization process, container & closure systems,
accelerated & room temperature stability data are reviewed to assure that
the drug will perform in an acceptable manner.
Labeling Review
 The labeling review process ensures that the proposed generic drug labeling
(package insert, container, package label & patient information) is identical
to that of the reference listed drug except for differences due to changes in
the manufacturer, distributor, pending exclusively issues, or other
characteristics inherent to the generic drug product (tablet size, shape or
color, etc.)
Bioequivalence Review Acceptable ?
 If at the conclusion of the Bioequivalence Review, it is determined that there

are deficiencies in the bioequivalence portion of the application, a
bioequivalence Deficiency Letter is issued by the division of Bioequivalence to
the applicant.
 This deficiency letter details the deficiencies & requests information & data
to resolve them.
Chemistry/Microbiology/Labeling
Review Acceptable ?
 If there are deficiencies involved in the Chemistry/Manufacturing/Controls,
Microbiology or Labeling portions of the application, these deficiencies are
communicated to the applicant in a facsimile.
 The facsimile instructs the applicant to provide information & data to address
the deficiencies & provides regulatory direction on how to amend the
application.
 Once the above sections are found to be acceptable, as well as, the pre-
approval inspection & bioequivalence portion of the application, then the
application moves toward approval.
Pre-approval Inspection Acceptable ?
 The pre-approval inspection determines compliance with Current Good

Manufacturing Practices (cGMPs) as well as a product specific evaluation the
manufacturing process of the application involved.
 If an unsatisfactory recommendation is received, a not approvable letter may
be issued.
ANDA Approved
 After all components of the application are found to be acceptable an

approval or tentative approval letter is issued to the applicant.
 If the approval occurs prior to the expiration of any patents or exclusivities
accorded to the reference listed drug product, a tentative approval letter is
issued to the applicant which details the circumstances associated with the
tentative approval of the generic drug product & delays approval until all
patent/exclusivity issues have expired.
 A tentative approval does not allow the applicant to market the generic drug
product
Patent Certification condition for ANDA
Described in section 505(j)(2)(A)(vii) of the Act.
I Patent Not Submitted to FDA
 Approval effective after OGD (Office of generic drugs)
scientific determination
II Patent Expired
 Approval effective after OGD scientific determination
III Patent Expiration Date (honored)

 Tentative approval after OGD scientific determination, final approval when patent expires
IV Patent Challenge
 Tentative approval after OGD science determination, final approval when challenge won
Paragraph IV certification
According to section 505(j)(2)(B)(i), 2157 CFR (CFR : Code of Federal

Regulations)
 The ANDA applicant must provide appropriate notice of a paragraph IV

certification to each owner of the patent that is the subject of the certification
and to the holder of the approved NDA to which the ANDA refers.
And by Section 505 (j)(5)(B)(iv)

 An incentive for generic manufacturers to file paragraph IV certifications and to
challenge listed patents as invalid, or not infringed, by providing for a 180-day
period of marketing exclusivity (to challenge to innoveter)
21 CFR Rules are a set of rules which govern or regulate the management and usage of electronic records in pharmaceuticals
and medical devices.
Patent Challenge Successful – Award of
180-Day Exclusivity Period
 Awarded to first ANDA holder to file a complete application with patent
challenge
 Protection from other generic competition – blocks approval of subsequent

ANDAs
Orphan Drug Exclusivity (ODE)
 Orphan drug refers to a product that treats a rare disease - affecting fewer
than 200,000 Americans.
 7 years exclusivity
 Granted on approval of designated orphan drug
 OGD ( Office of Generic Drugs ) works with the Office of Orphan Products
The Hatch-Waxman Amendments
 The "Drug Price Competition and Patent Term Restoration Act of 1984," also
known as the Hatch-Waxman Amendments,
 Established bioequivalence as the basis for approving generic copies of drug
products. These Amendments permit FDA to approve applications to market
generic versions of brand-name drugs without repeating costly and duplicative
clinical trials to establish safety and efficacy.
 Under the Hatch-Waxman Amendments, brand-name companies gained patent
term extension to account for the time the patented product is under review
by FDA and also gained certain periods of marketing exclusivity. In addition to
the ANDA approval pathway, generic drug companies gained the ability to
challenge patents in court prior to marketing as well as 180-day generic drug
exclusivity
Conclusion
References
 New Drug Approval Process, Richard Gaurino, Marcel DekkerINC, New York
 2nd Edition, Vol.56, 189-212. 2. www.fda.gov .

ANDA

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CHARAK COLLEGE OF PHARMACY AND

ABBREVIATED NEW DRUG APPLICATION (ANDA)

GUIDED BY : DR.A.V BHALERAO MAM

 Abbreviated New Drug Application

 An Abbreviated New Drug Application is an application for a U.S. generic drug

 Same active ingredient(s)

 To reduce the price of the drug.

 To reduce the time development.

 Increase the bioavailability of the drug in comparison to references list drug.

OGD - OFFICE OF GENERIC DRUG

CDER - CENTER FOR DRUG

Acceptable & Complete ?

 If the application is missing one or more essential components, a “Refuse to

 The Chemistry/Microbiology review process provides assurance that the

 If at the conclusion of the Bioequivalence Review, it is determined that there

 The pre-approval inspection determines compliance with Current Good

 After all components of the application are found to be acceptable an

III Patent Expiration Date (honored)

According to section 505(j)(2)(B)(i), 2157 CFR (CFR : Code of Federal

 The ANDA applicant must provide appropriate notice of a paragraph IV

And by Section 505 (j)(5)(B)(iv)

 Protection from other generic competition – blocks approval of subsequent

 Granted on approval of designated orphan drug

 2nd Edition, Vol.56, 189-212. 2. www.fda.gov .

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